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declaration de vigilance

English translation: Vigilance Incident report

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
French term or phrase:declaration de vigilance
English translation:Vigilance Incident report
Entered by: hduverle
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17:55 Oct 26, 2006
French to English translations [PRO]
Medical - Medical: Pharmaceuticals
French term or phrase: declaration de vigilance
Recherche biomedicale portant sur un dispositif medical
Formulaire
Declaration de vigilance: declaration initiale

I thought that this was simply declaration of vigilance, but when I tried to verify it, I didn't come up with too many hits. Is there another term for this?
Laura Miller
United States
Local time: 05:17
Vigilance Incident report
Explanation:
(Initial report, or final report)
I regularly have some of these from US > Fr
Selected response from:

hduverle
Local time: 05:17
Grading comment
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +1Pharmacovigilance initial (fill out or submission) form
Drmanu49
5Vigilance Incident report
hduverle
3vigilance system
Karen Tkaczyk
1pharmacovigilance certificate
Jonathan MacKerron


Discussion entries: 3





  

Answers


3 mins   confidence: Answerer confidence 1/5Answerer confidence 1/5
pharmacovigilance certificate


Explanation:
more or less

Jonathan MacKerron
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 28
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6 mins   confidence: Answerer confidence 5/5
Vigilance Incident report


Explanation:
(Initial report, or final report)
I regularly have some of these from US > Fr

hduverle
Local time: 05:17
Specializes in field
Native speaker of: Native in FrenchFrench
PRO pts in category: 44
Notes to answerer
Asker: Thanks Hervé! I also found medical device report, but that's for the FDA; this is for a European agency.

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5 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
Pharmacovigilance initial (fill out or submission) form


Explanation:
However, the submission of amendments (section 5), provision of pharmacovigilance reports (section 8) and notification of the conclusion or early ...
www.corec.org.uk/applicants/help/docs/REC_Approval_Conditio... -

Commission, for pharmacovigilance and for regulatory affairs. ... Candidates must fill out the form in one of the European Community languages. ...
www.emea.eu.int/pdfs/general/admin/recruit/043104en.pdf

Que se passe-t-il après transmission d’un EIG (rapport initial ou follow-up) à l’UFPV ? 10. Quelles peuvent être les conséquences de la déclaration d’un EIG ...
www.igr.fr/php/main.php?ids_path=2.52.654.656 - 16k

Where Pharmacovigilance reporting is required outside the remit of Clinical ... The initial report form will be used and changes will be made on the same ...
www.slam.nhs.uk/news/boardmin/docs/05sept06/PVPolicy28Jul06...

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Note added at 6 mins (2006-10-26 18:01:55 GMT)
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If the information contained in the initial submission (application form, ... other EU pharmacovigilance requirements (Volume 9 of the rules governing ...
ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2003/april/cp-guidance-eudract_230403.pdf -

Drmanu49
France
Local time: 11:17
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in FrenchFrench
PRO pts in category: 1025

Peer comments on this answer (and responses from the answerer)
agree  xxxSuzytrans
4 hrs
  -> Thank you Suzy.
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6 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
vigilance system


Explanation:
Laura, I don't have time to look it up just now but try looking based around 'vigilance system, not required', and you might get somewhere.

Karen Tkaczyk
United States
Local time: 03:17
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 166
Notes to answerer
Asker: Thanks Karen!

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